Article - Collaborative Study for Validation of a Serological Potency Assay for Rabies Vaccine (inactivated) for Veterinary Use

European Pharmacopoeia (Ph. Eur.) monograph 0451 on Rabies vaccine (inactivated) for veterinary use describes an in vivo batch potency test that is based on the NIH test. This assay uses a large number of mice and results in a significant degree of suffering. In the interest of replacement, reduction and refinement of animal tests (3R) a serological potency assay for Rabies vaccine (inactivated) for animal use, developed and validated at the Paul-Ehrlich-Institut, has been assessed in a collaborative study organised by the EDQM (European Directorate for the Quality of Medicines & HealthCare).